Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
cognitive-behavioral therapy
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, cognitive-behavioral therapy, tailored treatment
Eligibility Criteria
Inclusion Criteria: fibromyalgia according to the criteria of the American College of Rheumatology (ACR) Exclusion Criteria: physical or psychological comorbidity that interferes with cognitive-behavioral treatment participation in other clinical trials other psychological treatments pregnancy illiteracy difficulties with understanding Dutch language
Sites / Locations
- Jeroen Bosch Ziekenhuis, department of Medical Psychology
- Rijnstate Hospital, department of Rheumatology
- Radboud University Medical Centre, department of Rheumatology
- Radboud University Nijmegen Medical Centre, department of Medical Psychology
- Sint Maartenskliniek
Outcomes
Primary Outcome Measures
pain
disability
fatigue
psychological distress at post treatment and 6 month follow-up
Secondary Outcome Measures
passive coping
illness cognitions
social support at post treatment and 6 month follow-up
Full Information
NCT ID
NCT00268606
First Posted
December 21, 2005
Last Updated
May 20, 2008
Sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborators
Reumafonds, Radboud University Medical Center, Sint Maartenskliniek
1. Study Identification
Unique Protocol Identification Number
NCT00268606
Brief Title
Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk
Official Title
Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk: A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborators
Reumafonds, Radboud University Medical Center, Sint Maartenskliniek
4. Oversight
5. Study Description
Brief Summary
The present study is a new approach of examining tailored cognitive-behavioral interventions for fibromyalgia patients at risk. For this purpose, fibromyalgia patients are screened with respect to cognitive-behavioral risk factors and these patients are offered tailored cognitive-behavioral treatment options. It is expected that this approach will result in increased magnitude and maintenance of effects.
Detailed Description
The fibromyalgia syndrome is a chronic condition with widespread pain that poses a great challenge for patients, rheumatologists and society because of the lack of optimal treatment options. There is extensive evidence that, in comparison with patients with rheumatoid arthritis, fibromyalgia patients report higher levels of functional disability, pain, fatigue, and lower levels of quality of life. Although effectiveness of pharmacological agents and other interventions is generally limited, most promising effects have been found for non-pharmacological treatments, particularly those with a primary focus on cognitive-behavioral treatment components. However, also these treatment outcomes are characterized by large individual variation. Particularly patients with less impairments in daily life seem to benefit less from these treatments. In line with the international literature, previous findings of the research group suggest that effectiveness might be increased when tailored cognitive-behavioural treatments are solely offered to patients at risk.
In the present project the effects of tailored interventions based on cognitive-behavioral factors for patients at risk are studied. In a randomized, controlled trial, fibromyalgia patients are screened for risk profiles. Patients at risk will be assigned to tailored cognitive or behavioral treatment conditions, depending on their risk profile with respect to cognitive-behavioral factors. Half of the patients are subsequently randomly assigned to a waiting list control condition. It is expected that this tailored treatment approach will increase magnitude and maintenance of treatment effects for pain, disability, fatigue and increased quality of life, which means an important step forward for patients, involved professionals and society.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, cognitive-behavioral therapy, tailored treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
cognitive-behavioral therapy
Primary Outcome Measure Information:
Title
pain
Title
disability
Title
fatigue
Title
psychological distress at post treatment and 6 month follow-up
Secondary Outcome Measure Information:
Title
passive coping
Title
illness cognitions
Title
social support at post treatment and 6 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
fibromyalgia according to the criteria of the American College of Rheumatology (ACR)
Exclusion Criteria:
physical or psychological comorbidity that interferes with cognitive-behavioral treatment
participation in other clinical trials
other psychological treatments
pregnancy
illiteracy
difficulties with understanding Dutch language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A.W.M. Evers, Phd
Organizational Affiliation
Radboud University Nijmegen Medical Centre, department of Medical Psychology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
F.W. Kraaimaat, Prof. Phd
Organizational Affiliation
Radboud University Nijmegen Medical Centre, deparment of Medical Psychology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
W. van Lankveld, Phd
Organizational Affiliation
Sint Maartenskliniek, department of Reseach and Development
Official's Role
Study Chair
Facility Information:
Facility Name
Jeroen Bosch Ziekenhuis, department of Medical Psychology
City
's-Hertogenbosch
Country
Netherlands
Facility Name
Rijnstate Hospital, department of Rheumatology
City
Arnhem
Country
Netherlands
Facility Name
Radboud University Medical Centre, department of Rheumatology
City
Nijmegen
Country
Netherlands
Facility Name
Radboud University Nijmegen Medical Centre, department of Medical Psychology
City
Nijmegen
Country
Netherlands
Facility Name
Sint Maartenskliniek
City
Nijmegen
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
21926189
Citation
van Koulil S, van Lankveld W, Kraaimaat FW, van Helmond T, Vedder A, van Hoorn H, Donders AR, Wirken L, Cats H, van Riel PL, Evers AW. Tailored cognitive-behavioural therapy and exercise training improves the physical fitness of patients with fibromyalgia. Ann Rheum Dis. 2011 Dec;70(12):2131-3. doi: 10.1136/ard.2010.148577. Epub 2011 Sep 16.
Results Reference
derived
PubMed Identifier
21312345
Citation
van Koulil S, Kraaimaat FW, van Lankveld W, van Helmond T, Vedder A, van Hoorn H, Donders AR, Thieme K, Cats H, van Riel PL, Evers AW. Cognitive-behavioral mechanisms in a pain-avoidance and a pain-persistence treatment for high-risk fibromyalgia patients. Arthritis Care Res (Hoboken). 2011 Jun;63(6):800-7. doi: 10.1002/acr.20445.
Results Reference
derived
PubMed Identifier
20521308
Citation
van Koulil S, van Lankveld W, Kraaimaat FW, van Helmond T, Vedder A, van Hoorn H, Donders R, de Jong AJ, Haverman JF, Korff KJ, van Riel PL, Cats HA, Evers AW. Tailored cognitive-behavioral therapy and exercise training for high-risk patients with fibromyalgia. Arthritis Care Res (Hoboken). 2010 Oct;62(10):1377-85. doi: 10.1002/acr.20268.
Results Reference
derived
PubMed Identifier
19950305
Citation
van Koulil S, Kraaimaat FW, van Lankveld W, van Riel PL, Evers AW. A patient's perspective on multidisciplinary treatment gain for fibromyalgia: an indicator for pre-post treatment effects? Arthritis Rheum. 2009 Dec 15;61(12):1626-32. doi: 10.1002/art.24792.
Results Reference
derived
Learn more about this trial
Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk
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